Author: Association for the Advancement of Medical InstrumentationPublisher: Association for the Advancement of Medical Instrumentation (AAMI)
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 510
Book Description
Essential Standards for Biomedical Equipment Safety and Performance
Author: Association for the Advancement of Medical InstrumentationPublisher: Association for the Advancement of Medical Instrumentation (AAMI)
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 510
Book Description
Medical Devices. Recognized Essential Principles of Safety and Performance of Medical Devices. General Essential Principles and Additional Specific Essential Principles for All Non-IVD Medical Devices and Guidance on the Selection of Standards
Author: British Standards Institute StaffPublisher:
ISBN: 9780580843457
Category :
Languages : en
Pages : 60
Book Description
Medical equipment, Medical technology, Electrical medical equipment, Equipment safety, Safety measures, Performance, Selection, Standards, Acceptance (approval)
Medical Devices. Recognized Essential Principles of Safety and Performance of Medical Devices. General Essential Principles and Additional Specific Essential Principles for All IVD Medical Devices and Guidance on the Selection of Standards
Author: British Standards Institute StaffPublisher:
ISBN: 9780580913853
Category :
Languages : en
Pages : 50
Book Description
Electrical medical equipment, Safety measures, Equipment safety, Performance, Selection, Medical equipment, Acceptance (approval), Medical technology, Standards
Medical Device Safety
Author: G.R HigsonPublisher: CRC Press
ISBN: 1420033980
Category : Medical
Languages : en
Pages : 278
Book Description
Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety examines the prospects for achieving global harmonization in medical device regulation and describes a possible future global system. Unresolved difficulties are discussed while solutions are proposed. An essential book for all those involved in health physics, en
Inspection of Medical Devices
Author: Almir BadnjevićPublisher: Springer Nature
ISBN: 3031434447
Category : Technology & Engineering
Languages : en
Pages : 441
Book Description
This comprehensive guide invites nations worldwide to embark on a transformative journey, implementing independent third-party verification systems that ensure medical devices comply with both international and national regulations. Prepare to be captivated as we delve into the intricate processes, unveil essential procedures, and illuminate the paramount importance of establishing traceability for medical device measurements. Imagine a world where medical devices undergo rigorous independent safety and performance verification, guaranteeing the utmost reliability for patient diagnoses and treatment. This book takes you on a compelling exploration of precisely that vision. Focusing on cutting-edge diagnostic and therapeutic devices, it captures the very essence of the latest international directives and regulations, ensuring you stay ahead of the curve. This new edition goes beyond the conventional, delving into the realms of innovation and progress. Unveiling in-depth maintenance regimes within healthcare institutions, we provide you with invaluable insights into post-market surveillance. As the world embraces the transformative potential of artificial intelligence, we pave the way for evidence-based management of medical device maintenance—a concept poised to reshape the healthcare landscape. Imagine a future where medical devices are seamlessly integrated into the legal metrology system, while fully operational national laboratories for medical device inspection set new standards of excellence. This book vividly illustrates how such a powerful union can elevate the reliability of medical devices in diagnosis and patient care. Brace yourself for a paradigm shift that not only enhances efficacy but also leads to significant cost reductions within your country's healthcare system. Join us on this extraordinary journey as we unveil the untapped potential of medical device inspection. With our innovative approach and unrivaled expertise, together we can revolutionize healthcare, transforming the lives of countless patients worldwide. Get ready to be inspired, informed, and empowered—welcome to the future of healthcare!
Medical Electrical Equipment. General Requirements for Basic Safety and Essential Performance. Collateral Standard. Usability
Author: British Standards Institute StaffPublisher:
ISBN: 9780580634383
Category :
Languages : en
Pages : 78
Book Description
Electrical medical equipment, Medical equipment, Electrical equipment, Electronic equipment and components, Equipment safety, Electrical safety, Risk assessment, Ergonomics, Design
Medical Electrical Equipment. Particular Requirements for the Safety, Including Essential Performance, of Transcutaneous Partial Pressure Monitoring Equipment
Author: British Standards Institute StaffPublisher:
ISBN: 9780580340574
Category :
Languages : en
Pages : 40
Book Description
Medical equipment, Electrical medical equipment, Electrical equipment, Electronic equipment and components, Patient monitors, Clinical investigation instruments, Monitors, Pressure, Skin (body), Transducers, Oxygen, Carbon dioxide, Pressure measurement (fluids), Electrical safety, Safety, Performance, Performance testing
Medical Electrical Equipment. Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment
Author: British Standards Institute StaffPublisher:
ISBN: 9780580773198
Category :
Languages : en
Pages : 52
Book Description
Medical equipment, Electrical medical equipment, Electrical equipment, Electronic equipment and components, Safety engineering, Electrical safety, Safety measures, Ultrasonic medical apparatus, Ultrasonic devices, Clinical investigation instruments, Performance
Medical Device Regulations
Author: Michael ChengPublisher: World Health Organization
ISBN: 9241546182
Category : Medical
Languages : en
Pages : 54
Book Description
The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.
Medical Electrical Equipment. Particular Requirements for Basic Safety and Essential Performance of Oxygen Concentrator Equipment
Author: British Standards Institute StaffPublisher:
ISBN: 9780580879470
Category :
Languages : en
Pages : 58
Book Description
Electrical medical equipment, Medical breathing apparatus, Oxygen, Concentrators, Inhalation therapy equipment, Breathing apparatus, Medical equipment, Equipment safety, Marking, Accuracy, Performance, Safety measures, Hazards, Electrical safety, Performance testing, Fire safety, Protected electrical equipment, Strength of materials, Temperature-rise limit, Sound intensity, Gas flow, Flow measurement